Colorectal CancerNCT01478919
Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection
An observational study of Colorectal Cancer, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 127 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)
Who may be able to join
- all consecutive patients referred for EMR of LST
Who cannot join
- polyposis syndromes
- previous therapeutic attempt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors
Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.
- Conditions
- Colorectal Cancer
- Keywords
- Endoscopic Mucosal Resection, Laterally Spreading Tumor, Local Residual Neoplasia, Colonoscopy, Therapy
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Local Residual Neoplasia (LRN)
LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection
Measured: 3 months
Secondary outcomes (1)
Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)
Evaluation of selected patient- and lesion-related risk factors associated with LRN (gender, age, lesion size, location, morphology, pit pattern, histology, type of resection, and others)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Falt MD, Vitkovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478919
- Sponsor's protocol ID
- DDC VN 02
- Status last verified
- Sep 2013
- First submitted
- 21 Nov 2011
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Urban O, Kijonkova B, Kajzrlikova IM, Vitek P, Kliment M, Fojtik P, Falt P, Reiterova K, Horava V Jr. Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up. Eur J Gastroenterol Hepatol. 2013 Jun;25(6):733-8. doi: 10.1097/MEG.0b013e32835eda96.
PubMed 23442418
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors
- ClinicalTrials.gov ID
- NCT01478919
- Acronym / sponsor ID
- DDC VN 02
- Conditions
- Colorectal Cancer
- Keywords
- Endoscopic Mucosal Resection, Laterally Spreading Tumor, Local Residual Neoplasia, Colonoscopy, Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)
Key inclusion criteria (1 listed)
- all consecutive patients referred for EMR of LST
Key exclusion criteria (2 listed)
- polyposis syndromes
- previous therapeutic attempt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence of Local Residual Neoplasia (LRN)
Time frame: 3 months
LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection
1 secondary outcome
Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Background: PubMed 23442418Urban O, Kijonkova B, Kajzrlikova IM, Vitek P, Kliment M, Fojtik P, Falt P, Reiterova K, Horava V Jr. Local residual neoplasia after endoscopic treatment of laterally spreading tumors during 15 months of follow-up. Eur J Gastroenterol Hepatol. 2013 Jun;25(6):733-8. doi: 10.1097/MEG.0b013e32835eda96.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Vitkovice Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Local Residual Neoplasia (LRN) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.